BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4250188 · Received November 6, 2014

    Report

    Report Number
    3008642652-2014-03678
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    November 4, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY SN (B)(4) IS UNDERWAY. THE REPORTED PROBLEM (BATTERY WON'T POWER MONITOR) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY WAS UNABLE TO POWER ON A MONITOR AND CHARGE. THE BATTERY IS BEING RETURNED TO THE SUPPLIER FOR ROOT CAUSE INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT BATTERY SN (B)(4) WOULD NOT POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714297 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1